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CompletedNCT05922072Updated Jun 28, 2023

Comparison of Different Preoperative Fasting Times in Pediatric Patients Undergoing Elective General Anaesthesia

An interventional study of Nasogastric aspiration for measurement of Residual Gastric Volume and Nasogastric Aspiration for Measurement of Gastric pH in Pulmonary Aspiration of Gastric Contents, sponsored by King Edward Medical University. Completed at 1 site in Pakistan. Open to participants aged 1 Year to 12 Years. Per ClinicalTrials.gov, last updated 2023-06-28.

Sponsored by King Edward Medical University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Jun 2021, registered Mar 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
1 Year to 12 Years
Sex
All
01

Study summary

Rationale of this study is to provide an evidence on minimal safe clear fluid fasting duration without the risk of aspiration of gastric contents during elective pediatric procedures under general anesthesia.

Read the detailed description

Pre-operative fasting is a specific time period before a procedure in which participants will be advised not to take any liquid or solid by mouth. Nil per oral (NPO) is a universally accepted practice before elective general anesthesia in order to reduce gastric contents aspiration. In the period of chloroform anesthesia NPO was introduced because of vomiting and discomfort associated with anesthesia. Hence prevention from aspiration of gastric contents was a main focus during general anesthesia. With introduction of better anesthesia drugs recommendations were given to keep minimal fasting time before general anesthesia.

Recent guidelines suggest six, four and two hours fasting for solids/ infant formula milk, breast milk and clear fluids respectively. It is common practice to keep children NPO for 6 hours before surgery. But many times, children have to suffer excessive unnecessary fasting due to delayed surgery that lead to reduction in systolic blood pressure, induce catabolic state and behavioral effects. Moreover prolonged fasting increases insulin resistance and may increase the inflammatory response to surgery.

02

Conditions studied

  • Pulmonary Aspiration of Gastric Contents
03

In context

Respiratory Aspiration of Gastric Contents

28 studies on the registry are indexed under Respiratory Aspiration of Gastric Contents; 6 are open to participants now.

This study's enrollment of 120 is close to the median of 113 across 16 interventional studies indexed under Respiratory Aspiration of Gastric Contents.

Browse Respiratory Aspiration of Gastric Contents studies →

Lead sponsor

King Edward Medical University is the lead sponsor of 78 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Both male and female patients
  2. Age between 1 to 12 years
  3. Patients undergoing elective surgical procedures ( orchidopexy, lymph node biopsy, skin grafting, tongue ties and hernia repair ) under general anesthesia

Exclusion criteria

Exclusion Criteria:

1.Patients with co-morbidities like acid peptic disease with history of dyspepsia and family history or self-history of diabetes mellitus.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    Long NPO group

    6,4 and 2 hours NPO for solids/ formula milk, breast milk and clear fluid respectively

    Procedure: Nasogastric aspiration for measurement of Residual Gastric Volume · Procedure: Nasogastric Aspiration for Measurement of Gastric pH

  • Experimental
    Short NPO group

    6,4 and 1-hour NPO for solids/ formula milk, breast milk and clear fluid respectively

    Procedure: Nasogastric aspiration for measurement of Residual Gastric Volume · Procedure: Nasogastric Aspiration for Measurement of Gastric pH

Interventions

  • ProcedureNasogastric aspiration for measurement of Residual Gastric Volume

    The patients enrolled in this study undergoing elective general anesthesia,their mean gastric residual volume will be measured by taking Nasogastric tube aspirate.

  • ProcedureNasogastric Aspiration for Measurement of Gastric pH

    The patients enrolled in this study undergoing elective general anesthesia,their mean gastric gastric PH will be measured by taking Nasogastric tube aspirate.

06

What researchers measure

Primary outcomes

  1. Mean residual gastric volume

    Mean Residual Gastric Volume will be measured in mililiter

    Time frame: 6 Months

Secondary outcomes

  1. Gastric pH

    Gastric pH will be measured by pH Litmus paper

    Time frame: 6 months

07

Study locations

1 site
  • Paeds Surgery Department Mayo Hospital
    Lahore, Punjab 54000, Pakistan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05922072
Lead sponsor
King Edward Medical University
Responsible party
Fatima Numeri (Assistant Professor, King Edward Medical University) — Principal investigator
First posted
Jun 28, 2023
Start date
Jun 3, 2021
Primary completion
Dec 3, 2021
Completion
Dec 3, 2021
Last update
Jun 28, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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